THC DIRECT RIA KIT

Radioimmunoassay, Cannabinoid(s)

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Thc Direct Ria Kit.

Pre-market Notification Details

Device IDK781048
510k NumberK781048
Device Name:THC DIRECT RIA KIT
ClassificationRadioimmunoassay, Cannabinoid(s)
Applicant Immunalysis Corporation 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLAT  
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-06-21
Decision Date1978-10-03

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